ASAHI Masters PARKWAY SOFT. ASAHI Masters PARKWAY HF

Transcription

1 ASAHI Masters PARKWAY SOFT Microcatheter ASAHI Masters PARKWAY HF Microcatheter SYMBOLS 1 English 2 AMK-DT207 Ver.1.40 / 11TS028

2 SYMBOLS Legal manufacturer Consult instructions for use Do not use if package is damaged Microcatheter I.D. Do not reuse GC Minimum guiding catheter I.D. Do not resterilize Maximum injection pressure Caution, consult accompanying documents Maximum guide wire O.D. Use by Contents Contents Keep dry 1 Unit Keep away from sunlight STRAIGHT Distal end shape (straight) EC REP Authorized representative in the European Community Distal end shape (45 degree angled) LOT LOT number Stylet REF Catalogue number Microcatheter STERILE EO Sterilized using ethylene oxide 1

3 EN ASAHI Masters PARKWAY SOFT Microcatheter ASAHI Masters PARKWAY HF Microcatheter INSTRUCTIONS FOR USE Read these instructions before using this device and observe the Indications for Use, Contraindications, Warnings, Precautions, Malfunction and Adverse effects, How to Use, sections in the Instructions for Use. Failure to do so may result in complications, including serious injury to the patient or death. These Instructions for Use apply to the ASAHI Masters PARKWAY SOFT and ASAHI Masters PARKWAY HF Microcatheter. For details of the respective product, refer to the product label. Descriptions The outer surface of this microcatheter is coated with hydrophilic polymer in order to exert the lubricity when wet. Its lumen excluding the connector section is coated with PTFE to facilitate the movement of the guide wire and other devices. The entire shaft has a radiopaque structure, and the tip of the distal end has a radiopaque marker for clear identification. Tip Shaft Shape and structure Protector Marker Connector 2

4 Specifications Table 1 Specifications of ASAHI Masters PARKWAY SOFT and ASAHI Masters PARKWAY HF Microcatheter O.D. (Distal/Proximal) ASAHI Masters PARKWAY SOFT Microcatheter 0.66 mm/0.94 mm (1.98 Fr./2.8 Fr.) ASAHI Masters PARKWAY HF Microcatheter 0.88mm/0.93mm (2.6 Fr./2.8 Fr.) Microcatheter I.D mm (0.022 ) 0.69 mm (0.027 ) Maximum guide wire O.D mm (0.018 ) 0.53 mm (0.021 ) Minimum guiding catheter I.D mm (0.041 ) Maximum injection pressure 6895 kpa (1000 psi) This microcatheter can cope with the maximum pressure of 6895 kpa (1000 psi) when the distal end is open. Indications for Use This microcatheter is medical device intended for superselective angiography and/or infusion of various substances including diagnosis, embolization and treatment in peripheral vessels using an appropriate guiding catheter and guide wire. Do not use this product in the neuro and/or coronary vasculature. Contraindications Do not use this microcatheter for patients in pregnancy or patients who may be pregnant (X-ray may affect the unborn child). Warnings Failure to observe the following may result in life-threatening adverse effects. This microcatheter is presterilized with ethylene oxide gas (EOG) and is intended for single use only. Do not reuse or resterilize. If the package is opened or damaged, do not use this microcatheter. Do not open the package until just prior to use. Use aseptic technique in handling and using this microcatheter. Do not use this microcatheter after the expiration date indicated on the label. Do not modify this microcatheter for any reason. If this microcatheter meets resistance or any anomaly during use, do not continue operation. If it is suspected that the microcatheter is not normally operating, do not continue to operate the product. While paying much attention to possible complications, carefully withdraw the whole system. 3

5 Always check the position of the distal end of this microcatheter under fluoroscopy. When removing this microcatheter, insert the guide wire in advance. Read the instructions of use of the medical devices and the therapeutic agents used with this microcatheter. This microcatheter must be used only by a physician who is trained in peripheral intervention. Do not use this product for the purpose other than the purpose described in the descriptions above. Refer to Table 2 when using contrast medium or therapeutic agents with this product. Table 2 Injection into the microcatheter Immersion or wipe on the outer surface of the microcathter Ethanol Oil-based contrast medium (Lipiodol) Usable Usable Do not use Do not use Do not use Do not use Other organic solution Excessive repeat of insertion and/or withdrawal of the microcatheter may lower the performance of the hydrophilic coating If a power injector is used to inject a contrast medium or therapeutic agents, the injection pressure must not exceed 6895 kpa (maximum injection pressure). If this microcatheter is bent or blocked, do not inject a contrast medium or therapeutic agent. Do not use a guide wire larger than the maximum guide wire O.D. When inserting the guide wire while keeping the microcatheter inserted in a blood vessel, take particular care in inserting the guide wire. If the guide wire meets resistance or any irregularity when inserting or withdrawing, stop the manipulation, and withdraw the entire system. If this microcatheter is bent or twisted, do not insert the guide wire and avoid abrupt handling. If the microcatheter is inserted into a guiding catheter equipped with a stopcock, do not turn the stopcock to closed position. If using a hemostatic adapter (Y-connector/stopcock) with the guiding catheter, do not excessively tighten the hemostatic valve to the microcatheter, or do not manipulate the microcatheter while keeping the valve tightened. When injecting a contrast medium, inject by checking the flow of the contrast medium from the distal end of the microcatheter under fluoroscopy. If there is no flow from the distal end of the microcatheter, stop injecting the contrast medium. Precautions Prior to use, check the sterile bag is not opened or damaged, the product is not damaged, kinked, bend or crushed. If any damage is suspected with the sterile bag or this microcatheter, do not use the product. 4

6 To secure lubricity of the outer surface and the lumen of this microcatheter, moisten the outer surface with a heparinized saline and flush the lumen of this microcatheter with a heparinized saline while using this product. In addition, after withdrawing this microcatheter, immerse it in a heparinized saline to keep it moistened. In particular, after injecting a contrast medium or inserting therapeutic agent, sufficiently flush the lumen of this microcatheter with the heparinized saline. When shaping this microcatheter, use the stylet that is provided as the accessory and apply steam. Do not heat the microcatheter by other means. Do not apply excessive force or make an extremely small radius, or pinch it by forceps or fingers. Otherwise, the shaft may be deformed or crushed, the performance of the hydrophilic coating may be lowered. When removing the stylet, support the distal end of the microcatheter with fingers and pull the stylet out slowly. If using a syringe, carefully handle the syringe since injecting embolic material or therapeutic agent(s) into this product may tend to generate high pressure. If the syringe meets abnormal resistance, stop the injection. Against infection after using the microcatheter, take sufficient preventive measures, and discard it by appropriate means. Malfunction and Adverse effects During use of this microcatheter, the following malfunction and adverse effects may occur. If the malfunction and/or adverse effects are serious, it may induce death or a serious complication(s). Note, however, that malfunction and adverse effects are not limited to these. 1) Malfunction If an excessive force is applied to the microcatheter, the following malfunction may occur. Damage Kink (twist) Bend/crush Separation Damage to the hydrophilic coating Burst Withdrawal difficulty Insertion difficulty Occlusion of catheter lumen 5

7 2) Adverse effects Possible complications and adverse effects of using this microcatheter include, but are not limited to: Bleeding complications Ischemic complications Angiospasm Bradycardia/palpitation Embolism (air, tissue, thrombotic)/obstruction Damage to vessel including vessel dissection, vessel perforation and vessel rupture. Hematoma formation False aneurysm formation Infection How to Use Preparation 1) Remove this microcatheter together with the holder from the sterile bag. 2) Using a syringe, inject a heparinized saline into the holder from the flush connector. Check that the heparinized saline has been injected to the extent it spills from the other end of the holder. 3) Withdraw this microcatheter from the holder and check that the surface has lubricity. If the product meets resistance when withdrawing this microcatheter from the holder, inject a heparinized saline into the holder again to provide lubricity to this microcatheter. 4) Connect a syringe to this microcatheter withdrawn from the holder, flush the lumen with a heparinized saline, and fill the lumen of this microcatheter with the heparinized saline. Insertion 1) Insert this microcatheter along the guide wire inserted into the guiding catheter from a hemostatic adapter (Y-connector/ stopcock) connected to the guiding catheter. Advance this microcatheter and the guide wire to the distal end of the guiding catheter under fluoroscopy. 2) After checking the position of the distal end under fluoroscopy, advance the guide wire first, and thereafter advance the microcatheter to the intended position. 3) Withdraw the guide wire. Fix the connector of the microcatheter to the extension tube connected in advance to the power injector, and perform the injection. Refer to the flow rate in the Table of Flow Rate. If manually injecting the contrast medium, therapeutic agents or embolic material, connect the syringe to the connector of the microcatheter. 6

8 4) To prevent the blood from clotting to the inner surface of the microcatheter during the procedure, connect the syringe to the connector of the microcatheter as appropriate, and inject a heparinized saline. 5) To prevent blood from clotting to the surface of the microcatheter during the procedure, connect the syringe to the hemostatic adapter (Y-connector/ stopcock) connected to the guiding catheter, and flush the lumen of the guiding catheter with a heparinized saline as appropriate. Withdrawal After the procedure is completed promptly withdraw this microcatheter, and discard it by appropriate means. How to Store When storing the product, do not bend it or place it under a heavy object. In addition, take care not to expose the product to water, and avoid high temperature, high humidity and direct sunlight. Indicated on the product package label. Expiry date 1 set / box Content Liability Disclaimer By no means shall "ASAHI INTECC CO., LTD. and its affiliated companies" (hereinafter referred to as the "Company") be liable for accidents, personal injuries, adverse effects due to any improper use of the product(s) or any other use inconsistent with these instructions. In no event shall the Company be liable for any damages either (i) arising out of storage of the product(s) after the shipment from the Company or (ii) due to selection of patients, surgery techniques, or any other medical activities by the medical institution that uses the product(s). "ASAHI" and "Masters PARKWAY" are trademarks or registered trademarks of ASAHI INTECC CO., LTD. in Japan and other countries. 7

9 Table of Flow Rate Example result on injection test with auto injector 1.Equipment ZMA700modelA(Sugan Co., Ltd.) 2.Conditions Temperature of contrast medium 37 INJECTION PRESSURE MONITOR/LIMIT 4137kPa(600psi), 5532kPa(800psi), 6895kPa(1000psi) FLOW SCALE ml/sec LINEAR RISE SECONDS 0.3sec ASAHI Masters PARKWAY SOFT Effective length of product (cm) General name of contrast medium Iopamidol Iodine content (mg/ml) Viscosity (cp) Setting Parameter Obtained Flow Rate (ml/sec) Dead Space Volume (ml) FLOW RATE (ml/sec) VOLUME (ml) 4137kPa (600psi) 5532kPa (800psi) 6895kPa (1000psi) The flow rate in actual operation can be lower than this example result because of the variety of the viscosity of the contrast medium and/or other condition ASAHI Masters PARKWAY HF Effective length of product (cm) General name of contrast medium Iopamidol Iodine content (mg/ml) Viscosity (cp) Setting Parameter Obtained Flow Rate (ml/sec) Dead Space Volume (ml) FLOW RATE (ml/sec) VOLUME (ml) 4137kPa (600psi) 5532kPa (800psi) 6895kPa (1000psi) The flow rate in actual operation can be lower than this example result because of the variety of the viscosity of the contrast medium and/or other condition

10 ASAHI INTECC CO., LTD Akatsuki-cho, Seto, Aichi JAPAN Made in THAILAND EC REP Emergo Europe Molenstraat 15, 2513 BH, The Hague The Netherlands Tel: (31)(0) Fax: (31)(0) ASAHI INTECC CO., LTD. 16.Jun.2014(1 st edition)